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BMJ Open. 2017;7(10):e016617.

Study protocol for a randomised controlled trial: harmonising optimal strategy for treatment of coronary artery stenosis - coronary intervention with next-generation drug-eluting stent platforms and abbreviated dual antiplatelet therapy (HOST-IDEA) trial.

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제1저자 김치훈, 한정규 · 교신저자 김효수

소속 (12)
  1. Cardiovascular Centre, Department of Internal Medicine and Division of Cardiology, Seoul National University Hospital, Seoul, Korea.
  2. Department of Internal Medicine and Division of Cardiology, Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea.
  3. Department of Internal Medicine and Division of Cardiology, Kosin University Gospel Hospital, Busan, Korea.
  4. Department of Internal Medicine and Division of Cardiology, Inje University Busan Paik Hospital, Busan, Korea.
  5. Department of Internal Medicine and Division of Cardiology, Chonnam National University Hospital, Gwangju, Korea.
  6. Department of Internal Medicine and Division of Cardiology, Ajou University Hospital, Suwon, Korea.
  7. Cardiovascular Centre, Kwangju Christian Hospital, Gwangju, Korea.
  8. Department of Internal Medicine and Division of Cardiology, Soon Chun Hyang University Cheonan Hospital, Cheonan, Korea.
  9. Department of Internal Medicine and Division of Cardiology, Korea University Guro Hospital, Seoul, Korea.
  10. Department of Internal Medicine and Division of Cardiology, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
  11. Department of Internal Medicine and Division of Cardiology, Hallym University Kangdong Sacred Hospital, Seoul, Korea.
  12. Department of Internal Medicine and Division of Cardiology, Ewha Womans University Medical Center Mokdong Hospital, Seoul, Korea.

Abstract

INTRODUCTION We have recently seen the introduction of newer generation drug-eluting stents with ultrathin struts that use advanced polymer technologies. However, the efficacy and safety of these newest stents have not yet been fully explored. In addition, there are still controversies over the optimal duration of dual antiplatelet therapy (DAPT) after stent implantation, particularly for ultrathin stents with the newest polymer technologies.

METHODS AND ANALYSIS The HOST-IDEA trial is a randomised, open-label, multicentre, non-inferiority trial and the first study to directly compare two of these ultrathin sirolimus-eluting stents: Orsiro stent with biodegradable polymer, and polymer-free Coroflex ISAR (CX-ISAR) stent. This study has a scheme of 2×2 factorial design according to the stent type and DAPT duration (3 vs 12 months). A total of 2152 patients will be randomised and stratified to demonstrate the non-inferiority of CX-ISAR to Orsiro, or of the abbreviated DAPT duration to the conventional 12 months (both in 1:1 ratio). For the comparison of stent type, the primary endpoint is target lesion failure (TLF), which is a composite of cardiac death, target vessel-related myocardial infarction and clinically driven target lesion revascularisation. For the comparison of DAPT duration, the net adverse clinical event is the coprimary endpoint, which is defined as a composite of TLF, definite/probable stent thrombosis and major bleeding.

ETHIC APPROVAL AND DISSEMINATION All the institutions involved in this study are required to have ethical approval prior to patient enrolment. This multicentre study will recruit patients through competitive registration, but institutions that have not yet obtained ethical approvals have made it impossible to enrol patients in a centralised web database. The final results will be presented at relevant international conferences and will be materialised in the form of papers.

TRIAL REGISTRATION NUMBER NCT02601157; Pre-results.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Keywords

antiplatelet therapypolymerstent

Figures

Figure 1
Figure 1 Study outline and randomization scheme.

그림 출처: PubMed Central 공개 논문 (PMC5652478)

Comment · 정정

Conflict of interest statement

Competing interests: None declared.

그 밖의 정보
출판 형태
Journal Article, Multicenter Study, Randomized Controlled Trial
저널
BMJ open · eISSN 2044-6055
전자 출판
2017-10-11
MeSH
Absorbable Implants* · Clinical Protocols · Coronary Angiography · Coronary Stenosis / therapy · Drug-Eluting Stents* · Equipment Design · Female · Humans · Immunosuppressive Agents / therapeutic use · Male · Myocardial Infarction / etiology · Percutaneous Coronary Intervention / instrumentation / methods · Platelet Aggregation Inhibitors / therapeutic use · Polymers / therapeutic use · Sirolimus / therapeutic use · Thrombosis / etiology
Substances
Immunosuppressive Agents · Platelet Aggregation Inhibitors · Polymers · Sirolimus
데이터
ClinicalTrials.gov: NCT02601157
참고문헌
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